NCT00453258

Brief Summary

The significance of our study is in the importance of understanding the quality and quantity of proteins in the human tear film from diseased and non-diseased patients. This pilot study will provide data to plan prospective research to better delineate the utility of tear proteins in diagnosing and following disease status in a non-invasive fashion.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
63

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Feb 2007

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2007

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 26, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 28, 2007

Completed
4.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2011

Completed
Last Updated

January 17, 2013

Status Verified

October 1, 2012

Enrollment Period

4.6 years

First QC Date

March 26, 2007

Last Update Submit

January 15, 2013

Conditions

Eye Disease

Keywords

ocular proteomicseye diseaseproteomics

Outcome Measures

Primary Outcomes (1)

  • Plan Prospective Research

    Pilot study will provide data to plan prospective research to better delineate the utility of tear proteins in diagnosing and following disease status in a non-invasive fashion.

    Throughout study participation

Study Arms (1)

Study Subject

Subjects receiving eye examination

Other: Eye Examination

Interventions

Eye ExaminationOTHER

Subjects receiving eye examination

Study Subject

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Subjects receiving eye examination

You may qualify if:

  • years of age and older
  • able to cooperate with tear sample collection
  • provide written informed consent

You may not qualify if:

  • special populations (children, pregnant or lactating females, prisoners, etc)
  • refusal to sign sudy consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rocky Mountain Lions Eye Institute

Aurora, Colorado, 80045, United States

Location

MeSH Terms

Conditions

Eye Diseases

Study Officials

  • Malik Y. Kahook, MD

    Rocky Mountain Lions Eye Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 26, 2007

First Posted

March 28, 2007

Study Start

February 1, 2007

Primary Completion

September 1, 2011

Study Completion

September 1, 2011

Last Updated

January 17, 2013

Record last verified: 2012-10

Locations

US(1)